Pulsed Drug Delivery Engine for Plasma Profile Control

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Solution Overview

Problem

Current drug delivery systems are limited in their ability to precisely control the release of active pharmaceutical ingredients in the gastrointestinal tract and plasma, failing to mimic the desirable in-vivo characteristics of multiple dosing regimens, such as pulsed or multiple peaks, troughs, and plateaus, which limits bioavailability and treatment efficacy.

Innovation Solution

A drug delivery engine that uses a therapeutic composition with a core loaded with APIs and super disintegrants, coated with delayed release coats, allowing for precise control of the shape, number, magnitude, position, and timing of plasma concentration peaks, troughs, and plateaus through extended or pulsed release profiles, enabling better tolerance, reduced side effects, and improved compliance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If extended release dosage forms are used to control drug release, then bioavailability and maximum concentration are controlled, but the ability to deliver drug in a pulsatile manner with multiple peaks, troughs and plateaus is limited

Engineering Contradiction:

Improvecontrol of bioavailability and maximum concentrationVSAvoidability to deliver drug in pulsatile manner with multiple peaks, troughs and plateaus

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The dosage form is divided into multiple separate compartments or layers, each containing drug reservoirs with different release characteristics. This segmentation allows independent control of release profiles for each compartment, enabling generation of multiple plasma concentration peaks, troughs, and plateaus while maintaining reliable control over overall bioavailability and maximum concentration.

Inventive Principle:

Principle #1Segmentation

2Adaptability or versatility

If multiple dosing per day regimen is used, then desirable in-vivo characteristics with multiple peaks and troughs are achieved, but treatment compliance and convenience are reduced

Engineering Contradiction:

Improvein-vivo characteristics with multiple peaks, troughs and plateausVSAvoidtreatment compliance and convenience

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

Multiple dosing regimens that would normally require separate administration events are merged into a single unitary dosage form. The integrated system delivers multiple pulses of drug release within one administered unit, providing the desirable in-vivo characteristics of multiple peaks and troughs while maintaining the convenience and compliance of once-daily dosing.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The dosage form is pre-programmed with specific release profiles, timing, and sequences before administration. The release mechanisms are pre-configured to automatically generate the desired plasma concentration patterns without requiring patient intervention or adjustment, thereby maintaining treatment compliance while achieving complex in-vivo characteristics.

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If conventional drug delivery systems are used, then simple release profiles are achieved, but precise control over shape, number, magnitude, position and timing of plasma concentration peaks is limited

Engineering Contradiction:

Improvesimplicity of release profileVSAvoidprecise control over shape, number, magnitude, position and timing of plasma concentration peaks

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

The dosage form incorporates dynamic release mechanisms that can adjust or vary release rates in response to physiological conditions or time-dependent triggers. This dynamic capability enables precise control over the shape, number, magnitude, position, and timing of plasma concentration peaks while maintaining a relatively simple overall device structure that does not require complex external control systems.

Inventive Principle:

Principle #15Dynamics

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution provides superior control over drug release, enhancing bioavailability, reducing side effects, and improving treatment compliance by allowing for precise manipulation of plasma concentration profiles, offering a paradigm shift in controlled delivery technology.

Implementation Method 1

The API loaded core is coated with a delayed release coat as first coat

Methodology Applied

Scientific EffectDelayed release coating:

Implementation Method 2

a core loaded with up to 1000 mg of API and up to 1000 mg of a super disintegrant

Methodology Applied

Scientific EffectDisintegration:

Data Source

PatentUS10064828B1Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems

Publication Date: 2018.09.04 1001112561 ONTARIO INC

AI summary

The disclosure is directed to drug delivery devices that provide for combinations of extended and pulsed controlled release delivery of active pharmaceutical ingredient(s) APIs. The described drug delivery devices for oral administration of therapeutic compositions can include two or more populations of unit dosage forms including one or more API's in various combinations of pulsed and delayed/extended delivery formulations. The population of unit dosage forms are provided in a variety of different vehicles such as granules, beads, pellets, or tablets and can be contained within a drug delivery device of the present disclosure.